CTRI Number |
CTRI/2023/02/049367 [Registered on: 01/02/2023] Trial Registered Prospectively |
Last Modified On: |
31/01/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Observational |
Type of Study
|
Cross Sectional Study |
Study Design |
Other |
Public Title of Study
|
An observational study of Menstrual pattern in shift duty working women |
Scientific Title of Study
|
An observational study of Rajo-pravrutti pattern in shift duty working women |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Kirti Hanumant Jadhav |
Designation |
PG Student |
Affiliation |
PDEAs College Of Ayurveda and Research Centre,Nigdi,Pune 44 |
Address |
Department of Swasthavritta and Yoga, PDEAs College of Ayurveda and Research Centre, Nigdi, Pune
Pune MAHARASHTRA 411044 India |
Phone |
9822465715 |
Fax |
|
Email |
drkirtijadhav@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Rajkumar Bobade |
Designation |
HOD |
Affiliation |
PDEAs College Of Ayurveda and Research Centre,Nigdi,Pune 44 |
Address |
Department of Swasthavritta and Yoga, PDEAs College Of Ayurveda and Research Centre, Nigdi, Pune
Pune MAHARASHTRA 411044 India |
Phone |
9447319234 |
Fax |
|
Email |
rajkumarbobade@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Kirti Hanumant Jadhav |
Designation |
PG Student |
Affiliation |
PDEAs College Of Ayurveda and Research Centre,Nigdi,Pune 44 |
Address |
Department of Swasthavritta and Yoga, PDEAs College of Ayurveda and Research centre, Nigdi, Pune
Pune MAHARASHTRA 411044 India |
Phone |
9822465715 |
Fax |
|
Email |
drkirtijadhav@gmail.com |
|
Source of Monetary or Material Support
|
PDEAs College Of Ayurveda and Research Centre, Sector no 25, Nigdi ,Pune |
|
Primary Sponsor
|
Name |
PDEAs College of Ayurveda and Research Centre |
Address |
Nigdi Pune |
Type of Sponsor |
Research institution and hospital |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Kirti Jadhav |
PDEAs College of Ayurveda and Research Centre |
Department of Swasthavritta, Room No 123B, PDEAs College of Ayurveda and Research Centre, Sector No 25, Nigdi, Pune 411044 Pune MAHARASHTRA |
9822465715
drkirtijadhav@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethical Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
Menstrual pattern will be studied in women working in rotational shifts for more than 6 months |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
Inclusion Criteria
|
Age From |
20.00 Year(s) |
Age To |
40.00 Year(s) |
Gender |
Female |
Details |
Working for more than 6 months in shift duties |
|
ExclusionCriteria |
Details |
Pregnant women and lactating mothers
Subjects with major illnesses malignancy, HIV, tuberculosis.
Subjects using hormonal drugs oral contraception pills,
progesterone, oestrogen, glucocorticoid |
|
Method of Generating Random Sequence
|
Other |
Method of Concealment
|
Other |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
The study would reveal the effects 0f working in shift duties on menstrual pattern. |
52 weeks |
|
Secondary Outcome
|
Outcome |
TimePoints |
The study would reveal frequent gynecological pathologies occurring in women working in shifts. |
52 weeks |
|
Target Sample Size
|
Total Sample Size="150" Sample Size from India="150"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
02/02/2023 |
Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Ayurveda considers Nidra (sleep) as one among the three sub pillars of life which helps in the maintenance of the body, along with Aahara (food) and Brahmacharya(sexual life). All Acharyas are having the similar opinion that various aspects of happiness and sorrow, nourishment and emaciation, strength and weakness, knowledge and ignorance, life and death are all dependent upon sleep. Nidra is considered as one among the thirteen Adharaneeya Vegas. Shift work sleep disorders can be discussed under diseases due to Nidra Vegarodha (suppression of sleep), Nidra Naasha (insomnia) and Akaala Shayana (untimely sleep). As the natural urge for sleep in the night is being suppressed in relation with shift works, Nidra Vegarodha Janya Vikaraas (diseases due to suppression of sleep) are having significant role. Most disorders of female reproductive system are due to Vata Dosha vitiation. According to WHO, occupational health deals with all aspects of health and safety in the work place and has a strong focus on primary prevention of hazards.Circadian rhythms are physical, mental, and behavioral changes that follow a 24-hour cycle. Circadian rhythms can influence important functions in our bodies, such as: Hormone release, eating habits and digestion, body temperature. Increasingly, shift work and night work are becoming more common in our so called “24-hour†(or “24/7â€) society. This results in the sleep loss and misalignment of circadian rhythm with respect to sleep wake cycle. Studies of regular night-shift workers indicate that the circadian timing system usually fails to adapt successfully to such inverted schedules. Additional problems include higher rates of cancer and of cardiac, gastrointestinal and reproductive disorders in chronic night shift workers. The duration and pattern of menstrual cycle are considered as women’s reproductive health indicators. |